{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tucson",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91330",
      "recalling_firm": "SynCardia Systems LLC",
      "address_1": "1992 E Silverlake Rd",
      "address_2": "N/A",
      "postal_code": "85713-3865",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.",
      "recall_number": "Z-1022-2023",
      "product_description": "SynCardia Total Artificial Heart System (70CC): 500101-001    SynCardia Total Artificial Heart System (50CC): 570500-000",
      "product_quantity": "1,732 systems",
      "reason_for_recall": "Due to tears reported tears in the cannula due to wear and tear stress.",
      "recall_initiation_date": "20221102",
      "center_classification_date": "20230127",
      "report_date": "20230208",
      "code_info": "SynCardia Total Artificial Heart System (70CC): 500101-001   SynCardia Total Artificial Heart System (50CC): 570500-000"
    }
  ]
}